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- |||| REGN5713-5715 / Regeneron, REGN5715 / Regeneron, REGN5713-5714-5715 / Regeneron
Trial completion: Efficacy of the Anti-Bet v 1 Monoclonal Antibodies (Given Subcutaneously) to Reduce Allergic Rhinitis and Conjunctivitis Symptoms and Skin Test Reactivity Upon Exposure to Birch Allergen in Adult Participants (clinicaltrials.gov) - Aug 16, 2023
P2, N=218, Completed, Sponsor: Regeneron Pharmaceuticals
Active, not recruiting --> Completed
- |||| REGN5713-5715 / Regeneron, REGN5715 / Regeneron, REGN5713-5714-5715 / Regeneron
Enrollment open: Efficacy of the Anti-Bet v 1 Monoclonal Antibodies (Given Subcutaneously) to Reduce Allergic Rhinitis and Conjunctivitis Symptoms and Skin Test Reactivity Upon Exposure to Birch Allergen in Adult Participants (clinicaltrials.gov) - Oct 17, 2022
P2, N=300, Recruiting, Sponsor: Regeneron Pharmaceuticals
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- ||||| REGN5713-5715 / Regeneron, REGN5715 / Regeneron, REGN5713-5714-5715 / Regeneron
New P2 trial: Efficacy of the Anti-Bet v 1 Monoclonal Antibodies (Given Subcutaneously) to Reduce Allergic Rhinitis and Conjunctivitis Symptoms and Skin Test Reactivity Upon Exposure to Birch Allergen in Adult Participants (clinicaltrials.gov) - Jun 24, 2022
P2, N=300, Not yet recruiting, Sponsor: Regeneron Pharmaceuticals
- Efficacy of Anti-Allergen Therapeutics in a Preclinical Model of Allergic Anaphylaxis Correlates with Symptomatic Relief in Allergic Patients () - Apr 30, 2022 - Abstract #EAACI2022EAACI_998;
Blockade of individual mAbs versus mAb cocktails confirms optimal blocking efficacy of Fel d 1 mAb cocktail (REGN1908-1909) compared with either single mAb; Bet v 1 triple mAb cocktail (REGN5713-5714-5715) compared with single mAb (REGN5715) or dual mAb cocktail (REGN5713-5715). Conclusion Blockade of mast cell degranulation in the PCA mouse model correlates to efficacy in clinical settings, validating the model as a useful tool for selection of efficacious anti-allergen therapeutics.
- ||||||| REGN5715 / Regeneron, REGN5713-5714-5715 / Regeneron
Trial completion: Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis (clinicaltrials.gov) - Nov 9, 2021
P3, N=353, Completed, Sponsor: Regeneron Pharmaceuticals
Conclusion Blockade of mast cell degranulation in the PCA mouse model correlates to efficacy in clinical settings, validating the model as a useful tool for selection of efficacious anti-allergen therapeutics. Active, not recruiting --> Completed
- ||||| REGN5715 / Regeneron, REGN5713-5714-5715 / Regeneron
Enrollment closed: Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis (clinicaltrials.gov) - Jun 25, 2021
P3, N=353, Active, not recruiting, Sponsor: Regeneron Pharmaceuticals
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- |||||| REGN5715 / Regeneron, REGN5713-5714-5715 / Regeneron
Enrollment open: Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis (clinicaltrials.gov) - Feb 16, 2021
P3, N=300, Recruiting, Sponsor: Regeneron Pharmaceuticals
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- |||||||||| REGN5715 / Regeneron, REGN5713-5714-5715 / Regeneron
New P3 trial: Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis (clinicaltrials.gov) - Jan 14, 2021
P3, N=300, Not yet recruiting, Sponsor: Regeneron Pharmaceuticals
- REGN5713-5714-5715 / Regeneron
[VIRTUAL] ANTI-BET V_1 MAB COCKTAIL REDUCED BIRCH ALLERGIC SYMPTOMS WITHIN ONE WEEK, SUSTAINED OVER TWO MONTHS () - Nov 21, 2020 - Abstract #ACAAI2020ACAAI_512;
P1
Subjects had to achieve a TNSS (range 0-12) of >= 7 during NAC up-titration at screening to enter the study.Results Single-dose of REGN5713-5714-5715 significantly reduced TNSS following NAC relative to pre-dose baseline difference in TNSS AUC (0-1 hr) vs placebo (Day 8: −1.17, P=0.001; Day 29: -1.18, P=0.001; Day 57: -0.85, P=0.024) and titration SPT difference in AUC of mean wheal diameters vs placebo (Day 8: −2.54; Day 29: -2.27; Day 57: -2.78; Day 113: -2.46; all P<0.001), sustained for ≥2 months. REGN5713-5714-5715 is well-tolerated with treatment-emergent adverse events occurring at similar rates in treatment and placebo arms.Conclusion A single dose of a novel anti-Bet v_1 monoclonal antibody cocktail was well-tolerated and reduced birch allergic symptoms after birch allergen nasal provocation, potentially offering a new paradigm for the treatment of birch allergy.
- REGN5713-5714-5715 / Regeneron
[VIRTUAL] ANTI-BET V_1 MABS REDUCED BASOPHIL RESPONSIVENESS TO BIRCH POLLEN STIMULATION EX-VIVO IN BIRCH ALLERGIC PATIENTS () - Nov 21, 2020 - Abstract #ACAAI2020ACAAI_511;
Introduction a single dose of anti-Bet v_1 mAb cocktail (REGN5713-5714-5715) for treating birch allergy has previously shown effectiveness by reducing both nasal allergen challenge (NAC) symptoms and titration skin prick test (SPT) in a randomized, double blinded, placebo-controlled study (N=64)...Inverse correlation also existed between percent change in TNSS(0-1hr) AUC and EC50 for birch allergen on Day 8 (r=-0.71, p=0.0095).Conclusion The clinical efficacy of anti-Bet v 1 mAb cocktail in treating birch allergy may be explained by the suppression of basophil and mast cell mediated allergic response. Allergic response to alder and hazel may also be suppressed during treatment.
- ||| REGN5713-5714-5715 / Regeneron
Trial completion: Study to Assess the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of a Single Dose of REGN5713-5714-5715 in Healthy Adult Participants (clinicaltrials.gov) - Apr 27, 2020
P1, N=96, Completed, Sponsor: Regeneron Pharmaceuticals
Allergic response to alder and hazel may also be suppressed during treatment. Active, not recruiting --> Completed
- REGN5713-5714-5715 / Regeneron
Targeting birch allergy with monoclonal IgG antibodies that bind allergen and prevent IgE effector cell activation (Convention Center, 200 Level, Hall D) - Mar 1, 2020 - Abstract #AAAAI2020AAAAI_1215;
X-ray crystal structure data show simultaneous binding of REGN5713 and REGN5715 with more than half the surface area of Bet v 1 exposed. REGN5714 binds this exposed region, but cannot cover all of it, suggesting that masking 100% of the surface is not required to achieve maximal blocking potency.
- || REGN5713-5714-5715 / Regeneron
Enrollment closed: Study to Assess the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of a Single Dose of REGN5713-5714-5715 in Healthy Adult Participants (clinicaltrials.gov) - Jan 8, 2020
P1, N=96, Active, not recruiting, Sponsor: Regeneron Pharmaceuticals
REGN5714 binds this exposed region, but cannot cover all of it, suggesting that masking 100% of the surface is not required to achieve maximal blocking potency. Recruiting --> Active, not recruiting
- ||| REGN5713-5714-5715 / Regeneron
Enrollment open: Study to Assess the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of a Single Dose of REGN5713-5714-5715 in Healthy Adult Participants (clinicaltrials.gov) - Jun 25, 2019
P1, N=92, Recruiting, Sponsor: Regeneron Pharmaceuticals
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- ||| REGN5713-5714-5715 / Regeneron
New P1 trial: Study to Assess the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of a Single Dose of REGN5713-5714-5715 in Healthy Adult Participants (clinicaltrials.gov) - May 30, 2019
P1, N=92, Not yet recruiting, Sponsor: Regeneron Pharmaceuticals